SSI IMMUVIEW READER Bedienungsanleitung

ENGLISH (UK)

QUICK GUIDE

IMMUVIEW® READER

Instrument for automated

interpretation of results for

ImmuView®lateral ﬂow test

IMMUVIEW®READER

Introduction

This short ImmuView®Reader Quick Guide provides an overview of how to perform

a test with the ImmuView®Reader, and an ImmuView®strip. The ImmuView®

Reader is an instrument for automated interpretation of results for ImmuView®

lateral ow test.

This ImmuView®Reader is pre-set for basic daily use. You can customise your Im-

muView® Reader to t your personal settings and quality assurance requirements.

Please refer to the ImmuView®Reader manual for more detailed information about

the different functions of the reader.

Intended use

The ImmuView® Reader is an adjunctive instrument for automated reading and

interpretation of results for ImmuView® lateral ow immunochromatographic in

vitro diagnostics test strips.

Materials provided

The following content are supplied with the ImmuView®Reader:

• ImmuView®Reader

• 1 x Instrument check cartridge

• 2 x Strip-Carriers

• Power supply (With adaptors for US, EU, UK, Canada, and AUS)

• 3 x Ferrites (clip on for accessories only)

• 1 x Quick guide

• 1 x Certicate of Analysis (CoA)

Scan the QR code to access ImmuView®Reader

Manual via hyperlink or use the following link to access

it manually by entering this hyperlink in your browser:

http://ssidiagnostica.com/manualimmuviewreader/

The ImmuView® Reader, consumables, and its ports

Figure 1 ImmuView®Reader - Front View

Figure 2 ImmuView®Reader - Rear View

TFTLCD COLOUR

DISPLAY & TOUCH

SCREEN

LED STATUS

INDICATOR

USB

CONNECTION

USB

CONNECTION

ETHERNET

CONNECTION

CARTRIDGESTRIP

CARRIER SLOT

STRIP CARRIERINSTRUMENT CHECK CARTRIDGE

COMPANY LOGO

RATING LABEL

AUDIO SPEAKER

SERIAL NUMBER

UDI LABEL

SECURITY LOCK SLOT POWER CONNECTION POWER BUTTON

Start up the ImmuView®Reader

Turn on the reader by pressing and holding the power button for 2-3 seconds

(until a tone sounds). The power button is found on the left side of the ImmuView®

Reader (see picture of reader on page 3).

The start-up sequence is an automated test that is performed to verify correct

internal system functionality of the reader. If the reader is left turned on, the self-

test is automatically performed every 24hrs. The startup sequence takes around 3

minutes.

This is how the startup sequence appears on the ImmuView®Reader:

• Hourglass icon appears

• Loading bar appears and begins to load till full

•“ImmuView®” logo is displayed with indication

of start-up progress

Main menu

Once the start-up sequence is completed, the rst

screen you will see is “The Home menu screen”. You are

per default logged-in as Default User. To log-in push the

“key” button (lower left corner) and type in your initials.

The Home menu screen gives you the following options:

•Test, for running a test

•Results, for reviewing previously run test results

•Settings, for conguring the instrument

Further details and options for “Results” or user/admin

“Settings” can be found in the user manual.

How to run a test

Step 1: Press “TEST” on the Screen

The Test menu shows the different types of tests that

can be performed on the ImmuView®Reader:

•Perform Test

•Instrument Check

For further test settings, please refer to

section 8.7 in the user manual

Step 2: Press “Perform Test” on the screen

Step 3: Enter Patient ID

• Enter a unique patient ID using the onscreen

keyboard, or a scanner*.

•Press √ [Accept] to save the patient ID.

NB: If you Press X[Cancel] it cancels the test and test

data is not saved.

*A handheld scanner can be attached to the reader.

We recommend Datalogic QuickScan QD2430 2D

Step 4: Insert the strip into the Strip Carrier

Please refer to the section “How to insert the ImmuView®strip in the Strip Carrier”,

at the end of this quick guide, for a detailed description.

Step 5: Insert the Strip Carrier in the ImmuView® Reader

Insert the Strip Carrier (including the ImmuView®strip)

in the ImmuView® Reader when the screen says, “Insert

Test”. When you hear/feel a “click”, the Strip Carrier is in

place and the ImmuView® Reader will start to analyse the

strip.

Once you have inserted the Strip Carrier, no further actions are required.

The reading takes around 40 seconds.

When the reading is done, the test result will

automatically be shown on the screen.

The Strip Carrier must be left inserted in the ImmuView®

Reader during this phase of analysis.

Result

After the analysis, the ImmuView® Reader makes a

sound, to indicate that the analysis is nished.

This example shows that both Legionella and

S. pneumoniae are negative. Please also notice

the text “Control: VALID”, which indicates that

the test is valid.

Back Front

Strip placement

Make sure ”P&L” is visible & placed as shown in the picture.

You can remove the Strip Carrier from the ImmuView®Reader now.

ImmuView® Reader results outcomes:

A positive result will display a “Red Plus” next to the text.

A negative result will display a “Green Minus” next to the text.

Boil & Re-test Sample; and an IFU icon: Please refer to the ImmuView®IFU

interpretation of result section for further explanation.

Invalid; and an IFU icon: Potential error related to the Strip Carrier or the

ImmuView®strip. Refer to “How to insert the ImmuView®strip in the Strip

Carrier” section of this Quick Guide, and/or the ImmuView®IFU interpreta-

tion of result section.

The ImmuView®Reader will automatically save the result, which

can be accessed in the “Results” – please refer to section 8.12 in the

ImmuView®Reader user manual for more information.

To perform another test, press this icon.

To export the test result, press this icon.

Only possible if the ImmuView®Reader is connected to LIS or an

USB key is inserted into one of the ImmuView®Reader USB ports

If you want to go back to the main menu, press this icon (home)

To print the results, press this icon:

You need an external printer for this. We recommend the

Seiko Smart Label 620 Labelprinter.

Other essential features

Performing an Instrument Check

To perform an Instrument Check:

Follow step 1 and in step 2

[on page 5 in this Quick Guide] press the

‘Instrument Check’.

Unpack the Instrument Check Cartridge.

Follow Step 5 and insert the Instrument Check Cartridge

in the reader. The arrow on the Instrument Check

Cartridge needs to enter the

ImmuView®Reader

rst.

The

ImmuView®Reader

will perform the Instrument check.

The result will either be a pass or fail.

A pass describes that the

ImmuView®Reader

is within the specications.

A fail describes that the

ImmuView®Reader

is outside the specications, and the

reader is to be put in quarantine and sent to the supplier

(please refer to the manual).

Note: The

ImmuView®Reader

is by default pre-set to prompt the user every 7 days

for an Instrument Check.

LIS integration and other tasks

The ImmuView®Reader can be connected to the LIS system. Please refer to section 9.19

(Data connectivity) in the manual to learn how to transfer data from the ImmuView®

Reader to LIS.

Other features

Refer to the manual for detailed information of other

ImmuView®Reader

features

like printing results, storing data etc.

Instrument Check Cartridge

How to insert the ImmuView®strip in the Strip Carrier

Step 1: Follow the

procedure as

described

in the ImmuView®

S. pneumoniae &

Legionella IFU

Step 2: After 15 minutes remove

the ImmuView®strip from the

test tube, and gently dap off

excess sample uid, e.g. in a

napkin.

Step 3: Insert the ImmuView®strip in the Strip Carrier

Firstly, have a look at the design of the Strip Carrier, pictured bellowed.

Back

Front

”Finger” grip. To help to

insert and remove strip.

”Well” to ease the

removal of the strip

Insert strip here

THE STRIP CARRIER

Add test and wait

15 minutes

Add running buffer

and whirl gently

Sample addition

3 drops

(120 µL)

2 drops

(90 µL)

Legionella and

S. pneumoniae

positive

Legionella and

S. pneumoniae

positive*

Legionella

positive

S. pneumoniae

positive

Negative

Result interpretation

A: Control

B: Legionella

C: S. pneumoniae

* Look closely.

The intensity of

the lines B and C

may vary from

very clear to faint.

Invalid test

13246

Incomplete line -

retest sample

Three grey/purple

lines - boil

and retest

No control -

retest sample

No control -

retest sample

Next, follow step A, B and C, and you are ready to

insert the Strip Carrier in the ImmuView®Reader

A. Gently insert the ImmuView®strip in the Strip Carrier. Make sure “arrows”

 goinrst,andthe“P&L”textisattheback.

B. Continue to gently

push the ImmuView®

strip in the Strip Carrier.

C. Once the ImmuView®strip

reaches the front of the Strip

Carrier, the ImmuView®strip

is in place, and you can now insert

the Strip Carrier in the

ImmuView®

Reader

Step 4: Insert the Strip Carrier in the

ImmuView®Reader

(please see section 5 in the

Quick Guide for correct sequence).

On the reader it will say “insert test” when

it is time to insert the Strip Carrier.

Back Front

Strip placement

Make sure ”P&L” is visible & placed

as in the picture.

NOTICE THE ARROW.

The arrow always needs to be visible

when it is inserted in the reader or the

reader may report invalid results

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